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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN C000000035
Receipt No. R000000062
Scientific Title A Randomized Phase III trial of chemotherapy alone versus chemotherapy followed by gefitinib in stage IIIB/IV non-small cell lung cancer
Date of disclosure of the study information 2005/09/04
Last modified on 2005/09/04

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Basic information
Public title A Randomized Phase III trial of chemotherapy alone versus chemotherapy followed by gefitinib in stage IIIB/IV non-small cell lung cancer
Acronym A Randomized Phase III trial of chemotherapy alone versus chemotherapy followed by gefitinib in stage IIIB/IV non-small cell lung cancer
Scientific Title A Randomized Phase III trial of chemotherapy alone versus chemotherapy followed by gefitinib in stage IIIB/IV non-small cell lung cancer
Scientific Title:Acronym A Randomized Phase III trial of chemotherapy alone versus chemotherapy followed by gefitinib in stage IIIB/IV non-small cell lung cancer
Region
Japan

Condition
Condition Stage IIIB/IV Non-small cell lung cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 A randomized phase III trial of platinum-based chemotherapy alone versus platinum-based chemotherapy followed by maintenance therapy with gefitinib in patients with stage IIIB/IV NSCLC.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall survival
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Platinum doublet chemotherapy more than 3 cycles up to 6 cycles.
Interventions/Control_2 Platinum doublet chemotherapy 3 cycles followed by gefitinib except PD cases.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria Histologically or cytologically confirmed NSCLC
Stage IIIB/IV
No prior treatment
Measurable disease
ECOG PS 0-1
Adequate organ function
Age 20-74
Written informed consent
Key exclusion criteria Pregnancy or breast feeding
Past history of drug hypersensitivity
SVC syndrome
Pleural or pericardial effusion that required drainage
Active infection
Interstitial pneumonia or active lung fibrosis
Symptomatic brain metastasis
Active concomitant malignancy
Uncontrolled diabetes
Uncontrolled heart disease
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toyoaki Hida
Organization Aichi cancer center hospital
Division name Department of Thoracic Oncology
Zip code
Address 1-1 Kanokoden, Chikusa-ku, Nagoya
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization West Japan Thoracic Oncology Group (WJTOG)
Division name West Japan Thoracic Oncology Group (WJTOG)
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute West Japan Thoracic Oncology Group (WJTOG)
Institute
Department

Funding Source
Organization West Japan Thoracic Oncology Group (WJTOG)
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2005 Year 09 Month 04 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2003 Year 01 Month 20 Day
Date of IRB
Anticipated trial start date
2004 Year 04 Month 01 Day
Last follow-up date
2007 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2005 Year 08 Month 02 Day
Last modified on
2005 Year 09 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000062

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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